Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males

DISEASE CHARACTERISTICS:

• Men with a history of at least one male sexual partner
• "Men" is defined as those documented "male" at birth (including male-to-female transgendered persons)
• HIV-1 infection as documented by any federally approved, licensed HIV test performed in conjunction with screening (ELISA, western blot, or other approved test)
• Alternatively, this documentation may include a record that another physician has documented that the patient has HIV based on prior ELISA and western blot, or other approved diagnostic tests
• Meets one of the following sets of criteria:
• Patients receiving antiretroviral therapy:
• Receipt of antiretroviral therapy for at least 3 months prior to entry
• No change in antiretroviral therapy within 30 days prior to entry
• Patients not receiving antiretroviral therapy:
• CD4-cell count ≥ 350 cells/mm³ within 90 days prior to study entry
• No plans to start antiretroviral therapy prior to Week 28
• Normal anal cytological result, LSIL/condyloma, or ASCUS result within 90 days prior to entry, and no HGAIN on biopsy
• No current or history of anal or peri-anal carcinoma
• No anal cytological result of HSIL, atypical squamous cells suggestive of HSIL (ASC-H), or suggestive of invasive carcinoma at screening; or history of these results
• No presence of penile or scrotal condyloma, LGAIN (condyloma or AIN 1), HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3), or invasive carcinoma at pre-entry on biopsy
• No history of HGAIN

PATIENT CHARACTERISTICS:

• Karnofsky performance score ≥ 70 within 45 days prior to entry
• Absolute neutrophil count (ANC) > 750 cells/mm^3
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 100,000/mm^3
• AST (SGOT), ALT (SGPT) ≤ 3 times upper limit of normal (ULN)
• Total or conjugated (direct) bilirubin ≤ 2.5 times ULN within 45 days before study entry, with the exception of isolated hyperbilirubinemia that is considered due to atazanavir
• Calculated creatinine clearance ≥ 60 mL/min
• No hemophilia
• No active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
• No serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry
• No serious medical or psychiatric illness that, in the opinion of the site Investigator, will interfere with the ability of the subject to give informed consent or adhere to the protocol
• No allergy to yeast or any of the components of Gardasil

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior splenectomy
• No prior receipt of Gardasil or other HPV vaccine
• No use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry
• No expected use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids used for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or IVIG during study followup
• No patients with hepatitis C who expect to initiate treatment for hepatitis C (e.g., interferons) during this trial
• Not currently receiving anticoagulation therapy other than acetylsalicylic acid